Authentic pharmaceuticals are vulnerable to being diverted from e.g., legal pathways of distribution, for reasons of abuse (e.g. stealing pills to get high or to maintain addiction) or for unauthorized distribution and illegal sale (e.g, selling pharmaceuticals for profit on the gray market). When pharmaceuticals are misused or abused, they potentially pose danger to those who choose to use them in a manner other than as directed by a physician.
When law enforcement intercepts these diverted products, it may be difficult to determine their origin since they may not be in their original packaging. When a product is diverted, it is important to be able to identify/trace its origin in order to investigate and remedy the breakdown in integrity. A diffuse investigation wastes both time and resources (e.g. conducting searches of one factory, when the breech is in another factory). A delay in remedying the source of the diversion and/or counterfeiting can create more economic and personal harm. Remedying the problem quickly may serve to prevent further unintentional or intentional risk from misuse or abuse. Being able to authenticate the product and trace its manufacturing source may help to identify a breech in integrity quickly and efficiently.
Many pharmaceuticals are vulnerable to counterfeiting and false liability based on product substitution. After customers have acquired trust in products provided with a particular visually distinctive appearance, the products become vulnerable to counterfeiting, since a visually distinctive appearance can be susceptible to being imitated. Typically, a counterfeit product is made to resemble the genuine product as closely as possible with a view to misleading the purchaser into believing that the genuine product is being bought. Patients, pharmacists, wholesalers, and manufacturers may not be able to determine that the product is a counterfeit. Customers buy the counterfeit product with the expectation that they are buying the genuine product, with potentially life-threatening consequences, since the counterfeit may not meet the governmentally approved standard of quality, by providing treatment that is excessively potent, sub-therapeutic, or non-therapeutic. Being able to authenticate a product would assure quality and reduce risk. A method for marking a pharmaceutical that is not easily imitated or counterfeited, would help to authenticate the product.
There exists a need in the art, for compositions and methods of marking a pharmaceutical in a safe and reliable manner other than one that identifies it visually. In an effort to reduce misuse, abuse and diversion, and to comply with a risk management program, a new method of authentication and sourcing is disclosed.
All documents cited herein are hereby incorporated by reference in their entireties for all purposes.